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Transtibial Amputee Balance Training: A Randomised Controlled Trial

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ClinicalTrials.gov Identifier: NCT02572011
Recruitment Status : Terminated (Poor recruitment)
First Posted : October 8, 2015
Last Update Posted : March 14, 2019
Sponsor:
Collaborators:
Nottingham University Hospitals NHS Trust
University of Hull
Bournemouth University
Jonkoping University
Information provided by (Responsible Party):
Dr. Cleveland T. Barnett, Nottingham Trent University

Brief Summary:
Lower limb amputees have reduced joint mobility and strength which negatively influence an individual's ability to maintain balance. Individuals with lower limb amputation also have an increased fear of falling and reduced social participation because of this fear. Improving balance ability, reducing falls and fear of falling through effective balance training interventions would have a number of socio-economic benefits. The aim of the current study is to investigate whether taking part in a games console based-balance intervention, improves balance ability in individuals with lower limb amputation.

Condition or disease Intervention/treatment Phase
Lower Limb Amputation Other: Home-based Games Console Balance Training Not Applicable

Detailed Description:
Lower limb amputation (LLA) results in the loss of the biological joint structures such as the ankle and knee, along with the associated musculature. This reduces joint mobility and strength and thus adversely affects amputees' ability to maintain balance. As a result, individuals with a LLA have been shown to fall more often when compared to age-matched and otherwise healthy individuals. In addition, individuals with LLA also have an increased fear of falling and reduced social participation because of this fear. Improving balance ability, reducing falls and fear of falling in this patient group through effective balance training interventions would have a number of socio-economic benefits. Such benefits may include but are not limited to reduced care costs, reduced burden on healthcare services and an improved sense of patient well-being. Therefore, the main aim of the current randomised control trial (RCT) is to investigate whether taking part in a games console based-balance intervention, improves experienced LLAs balance ability. The RCT also aims to assess how this intervention affects an amputee's falls rate, fear of falling and quality of life. After providing informed consent, unilateral lower limb amputees will be randomly allocated to one of two groups; an experimental group (12-week balance training intervention) or a control group (no intervention). Amputees in the experimental group will be loaned the use of a games console for the duration of the home-based intervention. Balance ability, falls rate, fear of falling and quality of life will be assessed prior to and post the intervention period as well as after three months following the end of the intervention period. Falls rate will also assessed one year post the intervention period. Results from the current study will provide evidence for the use of games-console based balance interventions in improving balance and falls outcomes for LLA.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Games-console Based Balance Training Intervention for Transtibial Amputees: A Randomised Controlled Trial
Study Start Date : December 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arm Intervention/treatment
No Intervention: Control
Participants in the control (CON) group will not complete any formalised balance training as part of the current study.
Experimental: Experimental
Participants in the experimental group will complete the Home-based Games Console Balance Training intervention.
Other: Home-based Games Console Balance Training
The balance training intervention involves completing prescribed balance tasks for a minimum of 60 minutes per session, three times a week for 12 weeks (minimum intervention time of 2160 minutes) in their own home. Participants will perform the balance related Wii Fit games that have been suggested previously by professional bodies and amputee therapists (BACPAR Ossur Wii Fit Exercise Recommendations).




Primary Outcome Measures :
  1. Limits of Stability Test Protocol Directional Control Score [ Time Frame: Baseline to 3 Month Follow-Up ]
    Participants will also be required to complete the Limits of Stability test (LOS) which measures a participant's ability to perform postural movements in order to voluntarily move their centre of gravity (COG) as they stand on a force platform. The LOS requires participants to move their COG in the direction of eight pre-determined target directions as quickly and as accurately as possible. The eight pre-determined target directions will be representative of an individuals' 100% limit of stability based upon their height. Assuming that the body acts as an inverted pendulum with rotation about the ankle, this relates to the amount of movement possible before the COG position necessitates adjustment of the base of support by stepping. The directional control score (%) will be produced from this test protocol.

  2. The Berg Balance Scale [ Time Frame: Baseline to 3 Month Follow-Up ]
    Participants will complete the Berg Balance Scale, which involves the assessment of participants' ability to perform a number of functional tasks such as moving from standing to sitting, which are scored on a five point scale e.g. Needs assistance to sit (0) to sits safely with minimal use of hands (4). A total Berg Balance Scale score is calculated from this assessment.


Secondary Outcome Measures :
  1. Falling [ Time Frame: Baseline to 1 Year Follow-Up ]
    Falls, defined as an unexpected event in which the participant comes to rest on the ground, floor or lower level' will be recorded using prospective daily recording procedure with participants recording the occurrence of falls in a falls log book.

  2. Falls Efficacy [ Time Frame: Baseline to 3 Month Follow-Up ]
    Participants will complete the Modified Falls Efficacy scale in order to assess their falls efficacy.

  3. The Prosthesis Evaluation Questionnaire [ Time Frame: Baseline to 3 Month Follow-Up ]
    Participants will complete the Prosthesis Evaluation Questionnaire in order to assess their satisfaction with aspects concerning their prosthesis and their associated function.

  4. The Short form-36 Questionnaire [ Time Frame: Baseline to 3 Month Follow-Up ]
    Participants will complete the Short form-36 questionnaire to assess their quality of life.

  5. The Activities and Balance Confidence Scale [ Time Frame: Baseline to 3 Month Follow-Up ]
    Participants will complete the Activities and Balance Confidence Scale in order to assess their confidence in maintaining balance during activities of daily living.

  6. Centre of Mass Dynamics [ Time Frame: Baseline to 3 Month Follow-Up ]
    Participants biomechanical function, specifically the dynamics (movement) of their centre of mass, during the Limits of Stability Test protocol will be assessed in order to understanding the underpinning mechanisms of balance in this population.

  7. Limits of Stability Test Protocol Maximal Excursion Score [ Time Frame: Baseline to 3 Month Follow-Up ]
    Participants will also be required to complete the Limits of Stability test (LOS) which measures a participant's ability to perform postural movements in order to voluntarily move their centre of gravity (COG) as they stand on a force platform. The LOS requires participants to move their COG in the direction of eight pre-determined target directions as quickly and as accurately as possible. The eight pre-determined target directions will be representative of an individuals' 100% limit of stability based upon their height. Assuming that the body acts as an inverted pendulum with rotation about the ankle, this relates to the amount of movement possible before the COG position necessitates adjustment of the base of support by stepping. The maximal excursion score (%) will be produced from this test protocol.

  8. Limits of Stability Test Protocol Reaction Time Score [ Time Frame: Baseline to 3 Month Follow-Up ]
    Participants will also be required to complete the Limits of Stability test (LOS) which measures a participant's ability to perform postural movements in order to voluntarily move their centre of gravity (COG) as they stand on a force platform. The LOS requires participants to move their COG in the direction of eight pre-determined target directions as quickly and as accurately as possible. The eight pre-determined target directions will be representative of an individuals' 100% limit of stability based upon their height. Assuming that the body acts as an inverted pendulum with rotation about the ankle, this relates to the amount of movement possible before the COG position necessitates adjustment of the base of support by stepping. The reaction time score (s) will be produced from this test protocol.

  9. Limits of Stability Test Protocol Movement Velocity Score [ Time Frame: Baseline to 3 Month Follow-Up ]
    Participants will also be required to complete the Limits of Stability test (LOS) which measures a participant's ability to perform postural movements in order to voluntarily move their centre of gravity (COG) as they stand on a force platform. The LOS requires participants to move their COG in the direction of eight pre-determined target directions as quickly and as accurately as possible. The eight pre-determined target directions will be representative of an individuals' 100% limit of stability based upon their height. Assuming that the body acts as an inverted pendulum with rotation about the ankle, this relates to the amount of movement possible before the COG position necessitates adjustment of the base of support by stepping. The movement velocity score (degrees/second) will be produced from this test protocol.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unilateral transtibial amputee to fit research design and must have at least 12 months experience using their prosthetic limb independently following discharge from in-patient treatment
  • Minimum of 18 years old. There are no gender requirements − Age requirements in order to self-consent to participate, thus no child protection issues.
  • Able to travel − Data collection takes place at University campus where participants will attend data collection sessions.
  • Able to use prosthesis without pain or discomfort for a minimum of two hours at a time − Must be able to use prosthesis in order to complete tasks required for this research.
  • Able to stand for periods of up to 2 minutes, unaided and without walking aid to complete tasks required for assessment where participants are required to stand on a force platform and perform some volitional postural movements.

Exclusion Criteria:

  • Current musculoskeletal injury − Risk of further injury could be increased.
  • Unable to follow instruction or cognitive deficits − Risk of further injury whilst completing tasks incorrectly.
  • Bilateral amputation − In order to have a homogenous group of amputees in terms of categorisation of amputation.
  • Unable to perform tasks due to current medical condition e.g. rheumatoid arthritis − Risk of worsening current condition and/or causing further injury.
  • Experience pain or discomfort whilst wearing prosthesis - Risk of further injury and/or worsening of current condition. To be assessed by clinical team when individual is informed of study.
  • Does not use prosthesis regularly.
  • Not able to understand written and verbal English − All communication will be in English as the University does not have a service available that will be able to cope with translation demands.
  • Currently taking medication known to affect balance adversely - Risk of falling during balance training and/or data collection sessions.
  • Current Training - Participants must not be currently using the Nintendo Wii or similar systems in a structured balance training program.
  • Inability to provide informed consent
  • Substantial changes to the physical condition of the lower limb - If after consenting and participating in the study, individuals are referred to mobility services due to a degradation of the physical condition of either lower limb, they will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572011


Locations
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United Kingdom
The Biomechanics Lab, CELS Building, Nottingham Trent University
Nottingham, Notts, United Kingdom, NG11 8NS
The Mobility Centre, City Hospital, NUH NHS Trust
Nottingham, Notts, United Kingdom, NG5 1PB
Sponsors and Collaborators
Nottingham Trent University
Nottingham University Hospitals NHS Trust
University of Hull
Bournemouth University
Jonkoping University
Investigators
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Principal Investigator: Cleveland T Barnett, Ph.D Nottingham Trent University

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Responsible Party: Dr. Cleveland T. Barnett, Senior Lecturer in Biomechanics, Nottingham Trent University
ClinicalTrials.gov Identifier: NCT02572011     History of Changes
Other Study ID Numbers: NTU127818
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Cleveland T. Barnett, Nottingham Trent University:
Lower limb amputation
Transtibial
Balance
Postural Control
Limits of Stability
Rehabilitation
Home-based intervention
Nintendo Wii
Balance Board